Omega-3 Bioavailability From Vegetable-omega-3 Enriched Products

Sponsor
Commonwealth Scientific and Industrial Research Organisation, Australia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04610983
Collaborator
Agency for Science, Technology and Research (Other)
24
2
3
2.5
12
4.7

Study Details

Study Description

Brief Summary

CSIRO's Food Program has developed a novel vegetable-based Omega-3 long-chain polyunsaturated fatty acid (Omega 3)encapsulant to be used as ingredient in various food products, however, it is unknown whether the vegetable-based carrier matrix will affect omega-3 bioavailability. This project aims to compare the bioavailability of omega-3 from two test foods containing vegetable (cauliflower)-encapsulated algal oil (the "ingredient") against a control test product (algal oil gel capsules) across two ethnicities (Australian European vs. Chinese Singaporean).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Experimental: Control
  • Dietary Supplement: Experimental: Treatment 1 - Semi-Solid food matrix
  • Dietary Supplement: Treatment 2 - Solid food matrix
Phase 2

Detailed Description

Omega-3 long-chain polyunsaturated fatty acids (omega-3) (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) is associated with many health benefits including improved brain, heart, joint and eye health. However, <20% of the world's population consume adequate amounts of these fatty acids. Individuals who don't consume fish (major dietary omega-3 source) and particularly vegans/vegetarians are at greatest risk of omega-3 deficiency. Convenient strategies empowering consumers to increase their omega-3 intake have potential to significantly impact health outcomes. CSIRO's Food Program has developed a novel vegetable-based omega-3 encapsulant to be used as ingredient in various food products. Using algal oil as omega-3 source provides vegan/vegetarian options. However, it is unknown whether the vegetable-based carrier matrix will affect omega-3 bioavailability. As these products are intended for global markets, it is also unknown whether ethnic differences may affect omega-3 bioavailability. This project forms part of a larger project aiming to develop sensorially and culturally acceptable food products that incorporate vegetable-encapsulated omega-3 oils to assist Australian and Singaporean consumers to achieve their omega-3 LCPUFA intake. This component of the project aims to compare the bioavailability of omega-3 from two test foods containing vegetable (cauliflower)-encapsulated algal oil (the "ingredient") against a control test product (algal oil gel capsules) across two ethnicities (Australian European vs. Chinese Singaporean). To achieve this, two clinical trials, following the same protocol, will be executed in both Australia (Australian European) and Singapore (Chinese Singaporean).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A randomised, controlled, acute, 3-way cross-over study design will be usedA randomised, controlled, acute, 3-way cross-over study design will be used
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Bioavailability of Omega-3 Long-chain Polyunsaturated Fatty Acids (LCPUFA) From Foods Enriched With Vegetable-encapsulated Omega-3 Oils
Anticipated Study Start Date :
Nov 16, 2020
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Feb 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Control

Control 2 * Gel Encapsulated Algal Oil Capsules (each containing 200mg DHA) Total dose of 400mg DHA.

Dietary Supplement: Experimental: Control
2 x algal oil gel capsules delivering 400mg DHA in total

Experimental: Treatment 1 - Semi-Solid food matrix

Vegetable encapsulated algal oil integrated with a semi-solid food product (soup) to deliver 400 mg DHA.

Dietary Supplement: Experimental: Treatment 1 - Semi-Solid food matrix
Test Food 1: 200g serve soup + "ingredient"

Experimental: Treatment 2 - Solid food matrix

Vegetable encapsulated algal oil integrated with a solid food product (extruded snack) to deliver 400 mg DHA.

Dietary Supplement: Treatment 2 - Solid food matrix
Test Food 2: 50g serve extruded snack (savoury snack) + "ingredient"

Outcome Measures

Primary Outcome Measures

  1. Blood Plasma Omega-3 Concentration [0 Minutes (T0), 120 Minutes (T1), 240 Minutes (T2), 360 Minutes (T3), 480 Minutes (T4) and 1440 Minutes (T5)]

    Blood Plasma Omega-3 Concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy men

  • Age: 21-50 years old

  • BMI 18-27.5 kg/m2

  • Consume less than 2 meals of fatty fish/week

  • Not consume fish oil supplements over the past 3 months

  • Identify as Australian European in ethnicity (Australian with European heritage) for Australian arm of study

  • Identify as Chinese Singaporean in ethnicity (Singaporean with Chinese heritage) for Singaporean arm of study

Exclusion Criteria:
  • History of chronic disease - cancer, type 2 diabetes, cardiovascular disease, liver disease or any condition that may, in the opinion of the principle investigator, influence the study outcomes (Self reported, no clinical testing will be performed)

  • History of gastrointestinal disease, pancreatic insufficiency, conditions resulting in fat malabsorption - chronic pancreatitis, cystic fibrosis, coeliac disease, Crohns disease, gastric bypass surgery, small bowel resection, abnormal thyroid function (Self reported, no clinical testing will be performed)

  • Bleeding disorders, currently taking anticoagulants or has received anticoagulants within 28 days of Day 1 of the trial, with the exception of low dose aspirin up to150 mg daily (Self reported)

  • Any medical procedures deemed by the principal investigator to affect study outcomes

  • Known food allergies, hypersensitivity, dietary avoidance or intolerance to the study foods

  • Taking medications/supplements known to influence lipid metabolism and gastric emptying

  • On any weight-loss program

  • History of smoking during the 6 months prior to the study (Self reported)

  • Persons considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol

  • History of drug abuse or alcoholism (Self reported)

  • Participation in another research study within 30 days preceding the start of this study

Contacts and Locations

Locations

Site City State Country Postal Code
1 CSIRO, Health and Biosecurity Adelaide South Australia Australia 5000
2 A*STAR Singapore Singapore 117599

Sponsors and Collaborators

  • Commonwealth Scientific and Industrial Research Organisation, Australia
  • Agency for Science, Technology and Research

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Bradley Klingner, Project Manager and Principal Investigator delegate, Commonwealth Scientific and Industrial Research Organisation, Australia
ClinicalTrials.gov Identifier:
NCT04610983
Other Study ID Numbers:
  • OBP001
First Posted:
Nov 2, 2020
Last Update Posted:
Nov 2, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 2, 2020